Barthélémy, Eric

Bolognesi, Claudia

Castle, Laurence

Cravedi, Jean-Pierre

EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF)

Engel, Karl-Heinz

Fowler, Paul

Franz, Roland

Grob, Konrad

Gürtler, Rainer

Husøy, Trine

Kolf-Clauw, Martine

Kärenlampi, Sirpa

Lampi, Eugenia

Mennes, Wim

Milana, Maria Rosaria

Penninks, André

Silano, Vittorio

Smith, Andrew

Svensson, Kettil

Tavares Poças, Maria de Fátima

Tlustos, Christina

Wölfle, Detlef

Zorn, Holger

Zugravu, Corina-Aurelia

EFSA Journal

English

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the substance phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl) phenyl and 4-(1,1-dimethylpropyl) phenyl triesters. The substance was evaluated by the CEF Panel in 2011 and 2,4-di-tert-amylphenol, an impurity and hydrolysis product was re-evaluated by the CEF Panel in 2015. In this application, the applicant requested an increase of the specific migration limit of the substance, currently established at 5 mg/kg food, to 10 mg/kg food, and provided new toxicological studies. Findings from three new in vitro mutagenicity assays on the oxidation products support the conclusion from 2011 that the substance and its oxidation products are not genotoxic. A new toxicokinetic study on the substance supports the consideration from the evaluation in 2011 that the substance does not raise concern for accumulation. The outcome of a new delayed neurotoxicity study on a structurally related substance, phosphorous acid, tris (2,4-di-tert-butylphenyl) ester, which was considered not to cause neurotoxicity in hens, strengthens the conclusion of the Panel in 2011 that the substance does not represent a concern for neurotoxicity. From a new two-generation reproduction toxicity study and a prenatal developmental toxicity study on the substance, a new subchronic toxicity study on its oxidation products that completes the one submitted in 2011 on the substance itself, and a 2-year oral toxicity study on the structurally related substance, the lowest NOAEL was 58-147 mg/kg bw per day (from the 2-year oral toxicity study). Compared to the requested increase of the migration limit, this gives an acceptable margin of safety of 348. Therefore, the CEF Panel concluded that an increase of the specific migration limit of the substance from 5 to 10 mg/kg food is not a safety concern for the consumer

European Food Safety Authority

Engel, Karl‐Heinz

Zugravu, Corina‐Aurelia

Kolf‐Clauw, Martine

ProdInra

Safety assessment of the substance phosphorous acid, mixed 2,4‐bis(1,1‐dimethylpropyl)phenyl and 4‐(1,1‐dimethylpropyl)phenyl triesters for use in food contact materials

The Open University

Safety assessment of the substance phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters for use in food contact materials

Cravedi, Jean Pierre, J. P.

Engel, Karl‐heinz

Zugravu, Corina‐aurelia

HAL Université de Toulouse, et Toulouse INP

HAL: Hyper Article en Ligne

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Vittorio Silano

Claudia Bolognesi

Jean‐Pierre Cravedi

Karl‐Heinz Engel

Paul Fowler

Roland Franz

Konrad Grob

Rainer Gürtler

Trine Husøy

Sirpa Kärenlampi

Wim Mennes

Maria Rosaria Milana

André Penninks

Andrew Smith

Maria de Fátima Tavares Poças

Christina Tlustos

Detlef Wölfle

Holger Zorn

Corina‐Aurelia Zugravu

Martine Kolf‐Clauw

Eugenia Lampi

Kettil Svensson

Eric Barthélémy

Laurence Castle

Crossref

HAL ENVT (Ecole Nationale Vétérinaire de Toulouse)

https://hal.science/hal-01606831v1/file/10.2903_j.efsa.2017.4841_1.pdf

Safety assessment of the substance phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters for use in food contact materials

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